Breast CancerNCT04815616
Efficacy of Capecitabine With Adjuvant Radiotherapy in Treatment of Early Stages Breast Cancer (Retrospective Study).
An observational study of Breast Cancer, run by Assiut University.
Trial summary
1- Determine the efficacy and safety of concurrent capecitabine and external beam irradiation in patients with early stages breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early stage breast cancer Patients who received adjuvant Radiotherapy with capecitabine .
Who may be able to join
- Age of patients ≥ 18 years old patients.
- Histopathology confirmed: invasive ductal carcinoma.
- Breast conservative surgery or mastectomy.
- Early stage breast cancer patients.
- Adjuvant chemotherapy in the form of Anthracyclins based.
Who cannot join
- Contraindications to radiotherapy: such as previous irradiation to chest wall or skin diseases.
- Pregnancy or lactation.
- Contraindications to capecitabine such as: severe renal impairment Or hypersensitivity to capecitabine.
Trial locations and contacts
No sites are listed yet.
About this study
1- Determine the efficacy and safety of concurrent capecitabine and external beam irradiation in patients with early stages breast cancer.
Read the detailed description
Breast cancer is the most commonly diagnosed cancer among American women, In 2021 it is estimated that about 30%of newly diagnosed cancers in women will be breast cancer. As of January 2021, there are more than 3,8 million women with history of breast cancer in U.S.A including women currently being treated and those who finished treatment.
Death rates have been steady in women under 50years old since 2007,but have continued to drop in women over 50 years old .The overall death rate from breast cancer decreased by 1% per year from 2013 to 2018.these decreases are thought to be the result of treatment advances and earlier detection and screening.
About 43,600 women in U.S.A are expected to die in 2021 from Breast cancer. A woman's risk of breast cancer nearly doubles if she has a first degree relative who has been diagnosed with breast cancer .Less than 15% of women who get breast cancer have family member diagnosed with breast cancer. About 85% of breast cancer occur in women who have no family history of breast cancer ,these occurs due to genetic mutations that happen as results of aging process rather than inherited mutations. . [1]
The treatment of breast cancer includes the treatment of local disease with surgery, radiation therapy or both ,and systemic treatment with chemotherapy ,endocrine therapy ,biologic therapy or combination of these.[2]
After lumpectomy, whole breast irradiation is strongly recommended with or without boost to tumor bed for node positive (category 1 for those with positive nodes; category 2A for those with negative axillary nodes). This recommendation shows reduction in 10 -year risk of recurrence in those who received whole breast irradiation versus those who did not. In addition significant reduction in 15-year risk of breast cancer death was also observed. [3] Radiotherapy after mastectomy and Axillary lymph node dissection in (node positive disease) reduced both recurrence and breast cancer mortality in women with 1-3 positive lymph nodes even when systemic therapy was administered. [4] In node negative disease and tumor less than 5 cm and clear margin >1mm, post mastectomy radiation therapy is not recommended.
Primary radiotherapy has been used for local control of breast tumors in variety of situations. Excellent local control was obtained by Chargari et al with radiation alone in early stage tumors with loco regional control at 7 years of 95,8%. [5] Certain chemotherapeutic agents are known as radio-sensitizers, allowing for enhanced therapeutic ratio and improved tumor control when given concurrently with radiotherapy .concurrent chemo -radiotherapy has been used at multiple disease sites , with gains in local control, disease free survival ,and overall survival over radiation alone.[6] Combining adjuvant radiotherapy with capecitabine appears to be safe and feasible for chemotherapy resistant breast cancer patient with stage I-III who has residual disease in form of improve local and distant disease control [7].
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Capecitabine with adjuvant radiotherapy in treatment of Early Stages Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Adel Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815616
- Sponsor's protocol ID
- Radiotherapy in breast cancer
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1-. American Cancer society. .American cancer society. Cancer facts and figures 2021.available at: How common is breast cancer/ Jan 2021. http://www.cancer.org/content/dam/cancer-org/research/cancer-fact and ststics /annual- cancer-facts-and figures -2021.pdf. 2- stackievicz R ,Paran H ,Bernhiem J, et al. Prognostic significance of HER-2 /neu expression in patients with ductal carcinoma in situ. Isr med assoc j 2010 ;12:290-295 available at : http://www.ncbi.nlm.nih.gov,pubmed/20929083. 3-. early breast cancer trialists collaborative G, Darby S,Mc Gale P,et al. effect of radiotherapy after breast conserving surgery on 10-year recurrence and 15- year breast cancer death :meta-analysis of individual patients data for 10,801 women in 17 randomized trials .Lancet 2011;378:1707-1716 Available at: http:// www.ncbi.nlm.nih.gov,pubmed/22019144. 4-.early breast cancer trialists collaborative G, Darby S,Mc Gale P,et al. effect of radiotherapy after mastectomy and axillary surgery on 10- year recurrence and 20-year breast cancer mortality :meta-analysis individual patients data for 8135 women in 22 randomized trials. Lancet 2014; 383:2127-2135 available at: http:// www.ncbi.nlm.nih.gov,pubmed/24656685. 5-.Chargari C,Kirova YM,Laki F, et al. the impact of loco regional treatment in elderly breast cancer patients :hypo -fractionated exclusive radiotherapy, single institution long term results .breast 2010 ;19;413-6. 6-.Karasawa K,Saito M, Hariwatari H et al. the role of chemo radiotherapy in patients with unresectable T4 breast tumors breast cancer 2013;20:254-61. 7- N Engl J Med 2017; 376:2147-2159
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Capecitabine With Adjuvant Radiotherapy in Treatment of Early Stages Breast Cancer (Retrospective Study).
- ClinicalTrials.gov ID
- NCT04815616
- Acronym / sponsor ID
- Radiotherapy in breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
1- Determine the efficacy and safety of concurrent capecitabine and external beam irradiation in patients with early stages breast cancer.
Detailed description
Breast cancer is the most commonly diagnosed cancer among American women, In 2021 it is estimated that about 30%of newly diagnosed cancers in women will be breast cancer. As of January 2021, there are more than 3,8 million women with history of breast cancer in U.S.A including women currently being treated and those who finished treatment.
Death rates have been steady in women under 50years old since 2007,but have continued to drop in women over 50 years old .The overall death rate from breast cancer decreased by 1% per year from 2013 to 2018.these decreases are thought to be the result of treatment advances and earlier detection and screening.
About 43,600 women in U.S.A are expected to die in 2021 from Breast cancer. A woman's risk of breast cancer nearly doubles if she has a first degree relative who has been diagnosed with breast cancer .Less than 15% of women who get breast cancer have family member diagnosed with breast cancer. About 85% of breast cancer occur in women who have no family history of breast cancer ,these occurs due to genetic mutations that happen as results of aging process rather than inherited mutations. . [1]
The treatment of breast cancer includes the treatment of local disease with surgery, radiation therapy or both ,and systemic treatment with chemotherapy ,endocrine therapy ,biologic therapy or combination of these.[2]
After lumpectomy, whole breast irradiation is strongly recommended with or without boost to tumor bed for node positive (category 1 for those with positive nodes; category 2A for those with negative axillary nodes). This recommendation shows reduction in 10 -year risk of recurrence in those who received whole breast irradiation versus those who did not. In addition significant reduction in 15-year risk of breast cancer death was also observed. [3] Radiotherapy after mastectomy and Axillary lymph node dissection in (node positive disease) reduced both recurrence and breast cancer mortality in women with 1-3 positive lymph nodes even when systemic therapy was administered. [4] In node negative disease and tumor less than 5 cm and clear margin >1mm, post mastectomy radiation therapy is not recommended.
Primary radiotherapy has been used for local control of breast tumors in variety of situations. Excellent local control was obtained by Chargari et al with radiation alone in early stage tumors with loco regional control at 7 years of 95,8%. [5] Certain chemotherapeutic agents are known as radio-sensitizers, allowing for enhanced therapeutic ratio and improved tumor control when given concurrently with radiotherapy .concurrent chemo -radiotherapy has been used at multiple disease sites , with gains in local control, disease free survival ,and overall survival over radiation alone.[6] Combining adjuvant radiotherapy with capecitabine appears to be safe and feasible for chemotherapy resistant breast cancer patient with stage I-III who has residual disease in form of improve local and distant disease control [7].
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early stage breast cancer Patients who received adjuvant Radiotherapy with capecitabine .
Key inclusion criteria (5 listed)
- Age of patients ≥ 18 years old patients.
- Histopathology confirmed: invasive ductal carcinoma.
- Breast conservative surgery or mastectomy.
- Early stage breast cancer patients.
- Adjuvant chemotherapy in the form of Anthracyclins based.
Key exclusion criteria (3 listed)
- Contraindications to radiotherapy: such as previous irradiation to chest wall or skin diseases.
- Pregnancy or lactation.
- Contraindications to capecitabine such as: severe renal impairment Or hypersensitivity to capecitabine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyCapecitabine with adjuvant radiotherapy in treatment of Early Stages Breast Cancer | Radiation | – |
Primary outcome
Disease free survival
Time frame: baseline
Disease free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background1-. American Cancer society. .American cancer society. Cancer facts and figures 2021.available at: How common is breast cancer/ Jan 2021. http://www.cancer.org/content/dam/cancer-org/research/cancer-fact and ststics /annual- cancer-facts-and figures -2021.pdf. 2- stackievicz R ,Paran H ,Bernhiem J, et al. Prognostic significance of HER-2 /neu expression in patients with ductal carcinoma in situ. Isr med assoc j 2010 ;12:290-295 available at : http://www.ncbi.nlm.nih.gov,pubmed/20929083. 3-. early breast cancer trialists collaborative G, Darby S,Mc Gale P,et al. effect of radiotherapy after breast conserving surgery on 10-year recurrence and 15- year breast cancer death :meta-analysis of individual patients data for 10,801 women in 17 randomized trials .Lancet 2011;378:1707-1716 Available at: http:// www.ncbi.nlm.nih.gov,pubmed/22019144. 4-.early breast cancer trialists collaborative G, Darby S,Mc Gale P,et al. effect of radiotherapy after mastectomy and axillary surgery on 10- year recurrence and 20-year breast cancer mortality :meta-analysis individual patients data for 8135 women in 22 randomized trials. Lancet 2014; 383:2127-2135 available at: http:// www.ncbi.nlm.nih.gov,pubmed/24656685. 5-.Chargari C,Kirova YM,Laki F, et al. the impact of loco regional treatment in elderly breast cancer patients :hypo -fractionated exclusive radiotherapy, single institution long term results .breast 2010 ;19;413-6. 6-.Karasawa K,Saito M, Hariwatari H et al. the role of chemo radiotherapy in patients with unresectable T4 breast tumors breast cancer 2013;20:254-61. 7- N Engl J Med 2017; 376:2147-2159
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seham Adel Ali, Master degree (+201119817552, sehamadel24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.